ADVIA CHEMISTRY

Description of Event or Problem

THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS ON FOUR (4) PATIENT SAMPLES ON AN ADVIA® 2400 CLINICAL CHEMISTRY SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE SAME ADVIA® 2400 CLINICAL CHEMISTRY SYSTEM. THE REPROCESSED RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS.

Additional Manufacturer Narrative

AN OUTSIDE UNITED STATES (OUS) CUSTOMER CONTACTED THE SIEMENS HEALTHCARE DIAGNOSTICS REMOTE SERVICES CENTER (RSC) REGARDING ERRONEOUSLY DEPRESSED URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) RESULTS OBTAINED ON FOUR (4) PATIENT SAMPLES ON AN ADVIA® 2400 CLINICAL CHEMISTRY SYSTEM. SIEMENS IS INVESTIGATING THE EVENT.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION (11-JUL-2024): SIEMENS HEALTHCARE DIAGNOSTICS CONCLUDED THE INVESTIGATION OF THE EVENT. SIEMENS CONFIRMED THE POTENTIAL FOR BIASED QUALITY CONTROL (QC) AND PATIENT RESULTS WHEN USING ADVIA CHEMISTRY URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) LOT 140 ON THE ADVIA® 2400 CHEMISTRY SYSTEM. SIEMENS¿ INTERNAL INVESTIGATION CONFIRMED WHEN USING LOT 140, QC RECOVERED OUTSIDE OF THE ALLOWABLE CONTROL LIMITS FOR URINE CHEMISTRY CONTROL LEVELS. UNITED STATES (US) CUSTOMERS WERE NOTIFIED THROUGH AN URGENT MEDICAL DEVICE CORRECTION (UMDC) ACHC24-04.A.US.CHC, TITLED "ADVIA CHEMISTRY URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) LOT 140 QUALITY CONTROL (QC) OUT OF RANGE AND BIASED PATIENT RESULTS" AND OUTSIDE THE UNITED STATES (OUS) CUSTOMERS WERE NOTIFIED THROUGH AN URGENT FIELD SAFETY NOTICE (UFSN) ACHC24-04.A.OUS.CH, TITLED ¿ADVIA CHEMISTRY URINARY/CEREBROSPINAL FLUID PROTEIN (UCFP) LOT 140 QUALITY CONTROL (QC) OUT OF RANGE AND BIASED PATIENT RESULTS¿. CUSTOMERS WERE ADVISED TO DISCONTINUE USE AND DISCARD THE ADVIA UCFP LOT 140. INITIAL MDR 2432235-2024-00127 WAS FILED ON 06-JUN-2024.